Developing drug pipelines

Why did development processes have to change so drastically for the COVID-19 pandemic?

There is not a single aspect of life that hasn’t been affected by the COVID-19 pandemic – the unprecedented and rapid spread of the virus meant that changes to development processes were accelerated in order to curb the spread and begin to vaccinate the global population. By March 2020, COVID-19 had reached 114 countries, highlighting an urgent need for a global collective effort.¹ The vaccine development required clear communication of results and scientific findings, and collaboration from the likes of individual scientists at academic research institutes to biotechnology and pharmaceutical companies. Significant delays across the development process had to be significantly reduced or circumvented entirely – no matter how in-built they were to historic practices. To achieve this, it was first necessary to identify the main barriers within our existing processes across the industry; from regulation and approval, to manufacturing. Some of these barriers have, in the past, been exacerbated by fierce competition between companies over patents, time-to-market, and other areas. The limited timeframe for pushing a vaccine to market – around a year – seemed impossible; compounded by the standard of practice for vaccine development, where the average time from discovery to distribution is around ten years.² Prioritisation became key. This streamlining needed to be coupled with stringent scientific rigor to ensure that our outputs and discoveries were as safe, efficacious and transparent in their creation as any other product.

There were uncountable changes made to ensure fast delivery of COVID-19 vaccines. What were the key differences compared to usual development processes?

The most significant change was the shift towards collaboration at the local, national, and global levels with efforts from individuals, organisations, and governments. With communication in place, the healthcare industry was able to prioritise and divert funds and resources towards vaccine creation.³ There were five key changes to the standard vaccination developmental process,⁴ which were required to overcome significant barriers: regulatory actions were accelerated, with applications being approved within a matter of days rather than months; multiple phases of clinical trials occurred simultaneously, all while keeping safety measures intact; accessibility to real-time knowledge and data about the disease was provided to the wider scientific community; technological and scientific advancements, backed by decades of research, led to the development of two types of vaccines through novel platform technologies⁵: viral vectors and mRNA; companies manufactured at risk to reduce the timeline where multiple steps occurred simultaneously, such as vital materials being prepared before clinical trial phases were ready.⁶ With alterations to all of these steps, traditional barriers were overcome, without compromising safety, to streamline the approval the vaccines. Companies adapted their regular working schedules with some shifting to working 24/7 to aid development of COVID-19 vaccines, and coupled with all of these changes added together, have made history by developing a ‘one-year’ vaccine. However, these steps were made possible as a result of companies making financial risk investments and a global effort to divert funds and resources, steps which would be unsustainable in the long-term.

Are there any learnings from the development of vaccines that we can implement into drug development as standard practice?

Many. The developmental process was overhauled, and normal practices were expedited to introduce greater flexibility and speed to standard procedures, providing us with the opportunity to identify burdens and barriers that could be overcome in the future. It is currently uncertain how many of these practices will be retained in the long run, however, there is potential for regulatory collaboration, which could reduce the approach to drug development. During the pandemic these steps took a matter of weeks, where previously, changes have taken up to five years to implement.⁴ Regular publication and revision to guidance documents; accessibility to novel data, methods, and scientific knowledge; expedited review procedures for important clinical trials, with the potential of investment risks taken by companies should all be implemented into the standard practice.⁴ Clinical trials, as well as the whole healthcare industry, face the possibility of a more decentralised model, with a greater focus on telemedicine and direct-to-patient procedures.7 A more decentralised approach was used to collect clinical patient data, in an effort to keep patients safe, collection of bloods samples – used to monitor biomarkers and gain understanding of a drug’s properties – were moved from clinics to patients’ homes through mobile nursing services.⁸ As the focus on COVID-19 clinical trials lessens, those for other indications return to speed and will likely adopt these changes as standard practice. With these changes, we highlight another lesson from the pandemic that inclusion and access to healthcare is an important facet of the trial system, and that future changes should encompass the world’s populace. There is room for significant improvement in numerous areas of the developmental process of novel drugs and vaccines, such as manufacturing. However, it must be noted that the rate of infection and scale of investment during the COVID-19 pandemic was unprecedented and made the expedited development of the vaccine possible. Other vaccines could be developed as rapidly if infection levels are high, and there is an increased uptake of volunteers for clinical trials: without these two factors the developmental process will be inevitably longer. Companies with the ability to invest at risk can strive to aid therapeutic areas with unmet needs, but these financial steps need to be carefully thought out and may not become standard practice.

Are there any current processes that can be fast tracked to expedite drug development?

In time we will see the processes that can be fast-tracked, but currently, the focus should be on the need for alignment of priorities across all contributors to the healthcare sector: from public health, government and industry. During the pandemic, we have witnessed alignment of the vaccination programs to ensure vaccines are delivered globally. Although a difficult program to navigate, it required the alignment of incentives for all parties involved: without vaccinating enough of the global population, COVID-19 will continue to cause socio-economic hardship. Although it may not be feasible to fast-track all processes in the drug development pipeline, we can build on the existing collaboration solidified during the pandemic between the healthcare industry, governments, and pharmaceutical companies. This can provide opportunities to pool research and work together towards shared goals, rather than against each other. While the day-today nature of the pharmaceutical industry is competitive, I believe the changes we have seen during the COVID-19 pandemic will – if only in other times of crisis – remain a swift way to fast-track vital processes in drug development.

How can we ensure that processes are improved across the board, from public health crises to rare diseases?

As previously mentioned, COVID-19 provided a wake-up call for the healthcare industry. We’re seeing the potential for more proactive approaches to dealing with potential public health crises, and the opportunity to incorporate incentivised agendas with a requirement for global collaboration. This type of approach could be tailored, for example, to the growing argument for industry incentives to accelerate antibiotic R&D to counter antimicrobial resistance (AMR), where there is a need to balance an active drive to combat potential dangers before they become a critical reality – ensuring that the industry stays ahead of global threats, to avoid a catastrophe like COVID-19 again. In terms of rare diseases, there is a push to move from an approach of ‘one size fits all’ to personalised medicine – products and treatments tailored to one sub-population or even a single individual – with the hopes of revolutionising treatment methods. Clinical biomarkers and surrogate endpoints can have the potential to enable clinical diagnosis, treatment, and drug development in diseases with unmet needs, however, they require long and resourceintensive investments from multiple stakeholders. With that being said, J&J, as the world’s largest healthcare company⁹, is in a position to continue COVID- 19 vaccine development, whilst maintaining a strong R&D presence in many other therapeutic areas, including rare diseases. With appropriate allocation of resources, adapted structural changes, and a proactive rather reactive approach, pharmaceutical companies have the opportunity to address challenges from public health care crises down to rare diseases.

Kris Sterkens

Kris is Company Group Chairman of Janssen EMEA – appointed April 2017. Alongside his CGC, EMEA role, Kris is also Managing Director of Janssen Pharmaceutica, part of the Belgium Campus Leadership Team. Prior to 2017, Kris spent over three years in Singapore as CGC, Janssen Asia Pacific. Outside of his role, Kris is also the Chairman of the J&J Foundation, supporting the company’s wider societal responsibilities, and a member of the European Federation of Pharmaceutical Industries and Association (EFPIA).

References

1. WHO Director-General’s opening remarks at the media briefing on COVID-19 – 11 March 2020. Available at https://www.who.int/directorgeneral/ speeches/detail/who-director-general-sopening- remarks-at-themedia-briefing-on-covid- 19—11-march-2020. Accessed October 2021. 
2. Gouglas, Dimitrios et al. Estimating the cost of vaccine development against epidemic infectious diseases: a cost minimisation study. The Lancet 2018;6(12):e1386–e1396.
3. Wouters O J, et al. Challenges in ensuring global access to COVID-19 vaccines: production, affordability, allocation, and deployment. The Lancet 2021;397(10278):1023–1034. 
4. McKinsey & Co. Fast-forward: Will the speed of COVID-19 vaccine development reset industry norms. Available at: https://www.mckinsey.com/ industries/life-sciences/our-insights/fast-forwardwill- the-speed-ofcovid-19-vaccine-developmentreset- industry-norms. Accessed October 2021.
5. World Health Organization. The different types of COVID-19 vaccines. Available at: https://www. who.int/news-room/feature-stories/detail/therace- for-a-covid-19-vaccine-explained. Accessed October 2021.
6. van Riel D, de Wit E. Next-generation vaccine platforms for COVID-19. Nat. Mater 2020;19:810–812.
7. Shen Y-T, Chen L, Yue W-W, Xu H-X. Digital Technology-Based Telemedicine for the COVID-19 Pandemic. Front. Med 2020;8:646506.
8. No place like home? Stepping up the decentralization of clinical trials. Available at https://www.mckinsey.com/industries/ life-sciences/our-insights/no-place-like-homestepping- up-the-decentralization-of-clinical-trials (last accessed September 2021.)
9. About Johnson & Johnson. Available at https://www.jnj.com/about-jnj. (Accessed September 2021)